Regulatory Affairs & Quality Assurance Consultant

Are you an experienced regulatory affairs and quality assurance professional looking for a new challenge? If so, we have just the opportunity for you!

LFH is a top medical device consultancy company that is seeking a Regulatory Affairs & Quality Assurance Consultant for a fixed-term contract of 12 months with possible extension to join our dynamic team. We work with varying companies that have diverse ranges of technologies, offering a stimulating work environment and ample opportunities for professional growth and development. If you like working from home, know that this job is fully remote but with occasional travel.

Our services include device development and CE/UKCA marking certification, global regulatory strategies, US FDA, quality management system creation and ongoing support to ISO 13485, internal/supplier audits, remediating audit findings, technical documentation, risk management activities to ISO 14971, clinical requirements, recalls and adverse event management, product registration, and UK Responsible Person services.

Role Description

Client facing responsibilities, including, but not limited to:

The Regulatory Affairs & Quality Assurance Consultant will be responsible for managing client projects that include:

Onboarding new clients and exploring new business opportunities during client meetings.

Attending client meetings both remote and onsite as needed.

Creating regulatory strategies for global markets including classification of medical devices and IVDs.

Creating, maintaining, and conducting gap assessments on technical file documentation for clients, including, but not limited to:

• Risk management
• Post-market surveillance
• Essential Requirements Checklist (ERCs) and General Safety and Performance Requirements (GSPRs)
• Clinical Evaluation
• Biological Evaluation
• Usability Engineering
• Instructions for use and labels
• Applied standards

Registering devices with regulatory authorities.

Reviewing and preparing UK responsible person documentation.

Liaising with Notified/Approved Bodies and Competent Authorities.

Providing support to clients pre, during, and post-audit, including audit preparation, attending audits, and assisting with non-conformities.

LFH responsibilities, including, but not limited to:

Attending and participating in team meetings both remote and face to face.

Reviewing and providing feedback on documentation created for clients by colleagues.

Creating blog content for LinkedIn/Website and any other form of social media where required.

Creating, updating, and maintaining internal LFH Regulatory business processes and document employee training records.

Attending exhibitions, conferences, and networking events.

Requirements

Essential

• Minimum of 3-5 years of experience in regulatory affairs and/or quality assurance within the medical device/IVD industry.
• Willingness to learn and grow: We are looking for a motivated candidate who is eager to learn and grow as part of a team. A willingness to continuously develop your skills and contribute to the team’s success is essential.
• Problem-solving skills: As a Senior Regulatory Consultant, you’ll need to be a proactive problem solver. Your ability to anticipate issues, drive project consensus, and find solutions will be crucial in this role.
• In-depth knowledge of medical device regulations and standards, including EU MDR, IVDR, and ISO 13485.
• Experience with device development, quality management systems, audits, technical documentation, risk management, and clinical requirements.
• Strong understanding of recalls and adverse event management, product registration, and UK Responsible Person requirements.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Attention to detail and strong analytical skills.
• Relevant certifications or qualifications in regulatory affairs.
• Bachelor's degree or higher in a related field.

Desired

• US FDA experience.
• Experience with Software as a Medical Device (SaMD).
• Implementation of full and partial quality management systems by creating/writing procedures, controlled forms, and work instructions.

Benefits

Competitive Salary and compensation package: We understand the value of your skills and expertise. We offer a salary of up to £60k depending on experience.

Professional growth and development: As a Regulatory Affairs & Quality Assurance Consultant, you’ll have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation.

Stimulating work environment: Join a team at the forefront of medical device regulation, where every day brings new challenges and opportunities to make a difference. Collaborate with cross-functional teams and contribute to the development of crucial regulatory documents that impact the advancement of medical technology.

Apply now and become a part of this exciting journey!